F. David Rothkopf
Founder @Medicept Inc
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WORK HISTORY
Founder @Medicept Inc
Perform Quality System audits and assessments for compliance to FDA regulations, MDSAP, JPAL, ISO, and Canadian standards• Act as FDA liaison during FDA inspections• Participated in over 600 compliance audits• Specializing in Software, Design Controls, Production, and CAPAProvide Regulatory assistance • Acting Director of RA/QA at 3 Class II medical device & 2 Class medical device manufacturers• Assist firms with Regulatory Strategy• Develop 510k and PMA submissions – Seventy-three 510k, three DeNovo, and two PMA submissionsDevelop, implement, and maintain Quality System compliance programs and proceduresProvide Verification/Validation assistance – Protocol and Report creation• Packaging, Stability, Integrity – In-house testing facilities• Biocompatibility/Sterility/Cleaning• Design/Process – EquipmentProvide production, regulatory and quality compliance due diligence observations for merger and acquisition
EDUCATION
Questrom School of Business, Boston University
MBA, Entrepreneur
Worcester Polytechnic Institute
Master of Engineering - MEng
Worcester Polytechnic Institute
BSME, mechanical engineering
Worcester Polytechnic Institute
MSME, Manufacturing
SKILLS
ABOUT F. DAVID ROTHKOPF
I have more 30+ years of professional strategic experience in the corporate development and regulatory control of medical devices. I am the Founder at MEDIcept; established in 1996 to offer engineering, manufacturing, quality, and regulatory consulting assistance to the medical device and IVD industry. I am also an investor and serial entrepreneur, stating five medical device companies and successfully exiting out of two. I am now on the Board of Advisory member for six medtech companies and Reviewing Board Member at IRCM Institutional Review Board (IRB). I am a regulatory and technical advisor for the NIH\'s NHLBI Catalyze and HHS\'s ARPA-H Program. I also advises Doctoral MIT and Harvard students in regulatory affairs and am currently an adjunct faculty at MIT linQ, M+Vision Fellowship, and Idea2 programs and at Univ of Texas-Dallas School of Biomedical Engineering. In addition, I have presented at several professional organization meeting including RAPS, ASQ, and SQA annual meetings. My expertise includes technical and hands-on knowledge in a variety of business, regulatory, management, and quality processes. I have performed well over 600 ISO 13485 and FDA-style audits and been part of over 250 510ks, PMAs and Technical Files.In addition to MEDIcept Inc, David is President of SON Medical, a medical software consulting firm. He has a Bachelor and Master of Mechanical Engineering degree from WPI in Massachusetts and an MBA from Boston University.
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